Are the ‘Substances’ you use covered by the EU’s REACH Regulation?
September 8, 2009
As reported in the June 2009 issue of Powder Injection Moulding International (p.19) the European Union Regulation REACH, which stands for ‘Registration, Evaluation, and Authorisation of Chemicals’ came into force in June 2007.
The Regulation includes ‘substances’ such as metals, alloys and other raw materials, and obliges European producers to register the manufacture and use of ‘substances’ used in component manufacture.
The European Powder Metallurgy Association (EPMA) has issued a new update which addresses some of the questions relating to the registration of ‘substances’ used in powder metallurgy (PM) parts and whilst examples and templates for the registration process mainly refer to ferrous PM part manufacturing, the EPMA states that the questions are equally applicable to metal injection moulded (MIM) part manufacturers.
European PM part and MIM part producers use hundreds of chemical ‘substances’ every day, in very different fabrication processes: metals, organic compounds used in the binders and/or lubricants, post-sintering processing substances etc.
In future years all these ‘substances’ will have to be registered through separate dossiers under REACH by their Manufacturers and also Importers.
Since most of these dossiers will have to include the uses of the substances, REACH recommends an appropriate communication up and down the supply chain between the Manufacturers and Importers, and also the so called ‘Downstream Users’ (DU) of the substances which are effectively their customers and the customers of their customers right down to the consumers.
Under REACH most of the PM and MIM part producers are considered as ‘Downstream Users’.
The right to make a use of a ‘substance’ known
According to Article 37(2) the REACH Regulation gives the right to any DU to inform his supplier (Manufacturer or Importer or DU) about the use(s) of a substance either on its own, or in a preparation (powder mixture or alloy), with the aim of making this an identified use.
This should take the form either on paper or electronically, as a minimum, of a brief general description of uses. However the DU must be aware that, by starting this communication with the supplier of a substance, he commits himself to provide sufficient information (as stated in the REACH Regulation) to prepare the part of the Registration dossier where the uses and, for most dossiers, their related ‘exposure scenarios’ are described.
For pre-registered substances the supplier, according to Article 37(3), must take note of the request by the DU, provided that it is made 12 months before the registration deadline. Thus for substances which were pre-registered for a 1000 tons per year tonnage band the request should be made before the 1 December 2009.
Why does the PM/MIM industry need to communicate on ‘PM uses’?
The question could be raised whether DU PM or MIM companies should invest time and money to communicate on their uses of substances with its suppliers, especially in the current difficult economical circumstances. The answer is that if the PM/MIM company does not communicate, they may have to invest more time and money in the future if one of their uses is not taken into account in the Registration Dossier of a substance.
In fact according to Article 37(4), the DU of a substance must prepare the Chemical Safety Report for any use which is not identified by the Registrant. By communicating on the uses, the DU PM company passes on to the registrant the responsibility to assess the uses with the obligations laid down in REACH. Again the DU PM company should provide sufficient information for this part of the Registration Dossier.
Although the DU PM company should communicate on all uses and all associated substances, two cases can be distinguished where the communication of the uses is particularly recommended:
- When the PM company uses an established PM substances in particular way that the Registrant is not aware of
- When the PM company uses a non established PM substance in one of his PM processes so that the Registrant is not aware of its use in the PM industry.
One of these two scenarios may arise when the supply chain comprises several operators in the chain (e.g. distributors) between the substance Manufacturer or Importer and the PM DU company.
The recommendation of communication on PM uses is particularly strong when Aluminium, Cobalt, Nickel or Zinc (or their compounds) are involved in the PM processes even at a low percentage since they are already listed in the Dangerous Substances Directive.
Furthermore, since under REACH all chemicals are undergoing a thorough eco-toxicity check, the list is not definitive and the physical form of the substances (e.g. powder) may have an influence on their classification and therefore on the need of exposure scenarios.
How to provide sufficient information on PM/MIM uses to the suppliers?
Although there is no official template yet for the communication on uses by the DU, a first information form should comprise three parts which explain:
- A description of the process steps involved in the PM Use category: Thus the PM Use category ‘Pressing’ can include Raw Material Handling, Pressing, Green Handling and Green Machining, Cleaning and Maintenance.
- The Operational Conditions: It includes any action, use of tool or parameter state that prevails during use of substances that might have an impact on exposure on human and/or the environment (e.g. physical appearance of preparation, duration and frequency of use, amount of substance etc…).
- The Risk Management Measures in use: Measures that control the emission of a substance and/or exposure to it, thereby controlling the risk to human health or to the environment. At this stage of communication only qualitative information needs to be given.
In addition to this information form, a list of substances used in the process steps should of course be provided. Thus for the PM Use Category ‘Pressing’ or ‘Injection’, the associated list of substances should include all the powder or the feedstock constituents.
EPMA templates and examples
In order to help the PM and MIM communities to structure their communication on PM ‘substance’ Uses, the EPMA has developed, together with a small Task Force, templates for the communication on Uses, Occupational Conditions and Risk Management Measures from the Downstream User to the Registrant.
The following templates, accompanying documents and examples can be downloaded:
- Introduction to the Template for the communication on “PM uses” of Substances in the framework of REACH
- PM Downstream Use Information Form TEMPLATE
- List of Substances for Information Form TEMPLATE
- Codes for Exposure Scenarios for PM
- Example 1 – PM Downstream Use Information Form for Powder Mixing
- Example 2 – PM Downstream Use Information Form for Pressing
- Example 3 – PM Downstream Use Information Form for Sintering
- Example of List of Substances for Pressing and Sintering
- Example of List of Substances for Packed Powder Mixing
Codes for Exposure Scenarios for PM
In addition to the Information Forms, it may be necessary to provide generic codes provided by the European Chemical Agency to describe the use(s) of substances. The EPMA has listed the corresponding codes for the PM industry in the Codes for Exposure Scenarios document.
The present documents are drafts developed with the latest know-how status. They will be updated regularly according to the latest developments and you are invited to check the Revision Number of the drafts.
Who should receive the Information Form and List of Substances?
The Information Form should be sent to:
- Direct supplier(s) dealing with the substances involved in the ‘List of substances’
- The REACH community in general (SIEF, Consortia, Substance Based Organisations etc…)
- The EPMA who can help you finalise your Information form and forward it to the REACH community.
Even if most PM companies are only DU of substances and are therefore not responsible for the registration, they should definitely establish a contact up the supply chain regarding the uses they make of substances and ensure that the information reaches the Registrants of the substances.
Since it is not necessary, in a first step, to send detailed and quantitative information, the EPMA recommends using the Templates mentioned above for a simple but clear communication. However the clock is ticking as early deadlines for the communication of uses apply.
The EPMA states that its web page “DU Communication Tools on PM Uses” will be updated in the near future and the PM community is invited to check regularly the revision number of the drafts (e.g. Codes for Exposure Scenarios for PM).
Finally further explanations, discussion and examples on the DU Communication will be addressed during the next EPMA REACH Workshop on 17th and 18th September in Brussels.
Further information can also be obtained from Dr. Olivier Coube, EPMA Technical Director; Email: [email protected]